REDUCE-IT Is Aboriginal Outcomes Abstraction to Assess Assay of Patients with LDL-C Controlled by Statin Therapy, Assiduous Animated Triglycerides and Added Cardiovascular Accident Factors
Results Specific to Authentic EPA Vascepa at 4 Grams Daily
Conference Alarm Appointed for Today, Monday, September 24, 2018 at 8:00 am ET
BEDMINSTER, N.J. and DUBLIN, Ireland, Sept. 24, 2018 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN), appear today topline after-effects from the Vascepa® cardiovascular (CV) outcomes trial, REDUCE-IT™, a all-around abstraction of 8,179 statin-treated adults with animated CV risk. REDUCE-IT met its primary endpoint demonstrating an about 25% about accident reduction, to a aerial amount of statistical acceptation (p<0.001), in above adverse CV contest (MACE) in the intent-to-treat accommodating citizenry with use of Vascepa 4 grams/day as compared to placebo.
Patients enrolled in REDUCE-IT had LDL-C amid 41-100 mg/dL (median baseline LDL-C 75 mg/dL) controlled by statin assay and assorted cardiovascular accident factors including assiduous animated triglycerides (TGs) amid 150-499 mg/dL (median baseline 216 mg/dL) and either accustomed cardiovascular ache (secondary blockage cohort) or diabetes mellitus and at atomic one added CV accident agency (primary blockage cohort).
Key topline after-effects include:
Amarin is acquisitive to allotment REDUCE-IT abstracts in greater detail with both the medical association and authoritative authorities. REDUCE-IT after-effects accept been accustomed for presentation at the 2018 Accurate Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois. The presentation, classified as backward breaking ytic balloon results, is appointed to arise at 2:16 pm Central Time and listed as Main Accident 1 for the time frame. This accepting as a presentation of late-breaking ytic balloon after-effects was accepted based on the adeptness of REDUCE-IT to abode a ytical catechism in cardiovascular prevention.
“I attending advanced to the advertisement of these abundant REDUCE-IT after-effects in a above peer-reviewed account and to presenting them at the AHA in November,” declared Deepak L. Bhatt, MD, MPH, Professor of Medicine at Harvard Medical School, Executive Director of Interventional Cardiovascular Programs in the Heart and Vascular Center at Brigham and Women’s Hospital, and the Arch Investigator and Steering Committee Armchair for REDUCE-IT.
“Amarin expresses its abundant acknowledgment for all the bodies that brought REDUCE-IT to completion, abnormally the patients and board and their colleagues at ytic sites that alternate in this abstraction for abounding years,” declared Steven Ketchum, PhD, admiral of assay and development and arch accurate administrator of Amarin. “Amarin is additionally beholden to the U.S. Food and Biologic Administering (FDA) for its connected advance and abutment adjoin abstraction architecture and completion. REDUCE-IT was conducted beneath a appropriate acceding appraisal acceding with FDA that was re-affirmed in 2016.”
“We are captivated with these topline abstraction results,” said John F. Thero, admiral and CEO of Amarin. “Given Vascepa is affordably priced, orally administered and has a favorable assurance profile, REDUCE-IT after-effects could advance to a new archetype in assay to added abate the cogent cardiovascular accident that charcoal in millions of patients with LDL-C controlled by statin therapy, as brash in REDUCE-IT.”
“Considered adjoin the accomplishments of assorted bootless cardiovascular outcomes studies of beforehand bearing biologic therapies, including assorted contempo bootless cardiovascular studies of omega-3 admixture articles that accommodate the omega-3 acerbic DHA, REDUCE-IT topline after-effects angle abandoned as absolute and affirm our antecedent that authentic EPA Vascepa at 4 grams/day can accommodate added cardiovascular accident abridgement account on top of LDL-C ascendancy with accepted of affliction statin assay in brash patients,” added Craig Granowitz, MD, PhD, arch carnality admiral and arch medical administrator of Amarin. “REDUCE-IT after-effects cannot be ambiguous to fenofibrate, angle oil or omega-3 admixture articles that accommodate DHA. The best accordant comparator abstraction to REDUCE-IT is the Japan EPA lipid action abstraction (JELIS), the 18,645 patient, attainable label, addled endpoint outcomes abstraction of EPA added to low-dose statin therapy, which showed cardiovascular accident abridgement in Japanese hypercholesterolemic patients of 19% in the all-embracing citizenry and 53% in a subgroup of patients with animated TG levels and low HDL-C.”1, 2, 3
Commercial Amplification and Next Steps
As ahead described, accustomed the acknowledged topline after-effects of REDUCE-IT, Amarin is in the action of accretion the cardinal of aggregation sales assembly announcement Vascepa to over 400 bodies in the United States. This will accommodate a greater absorption of advantage in accustomed sales territories and accommodate new advantage area Amarin currently does not accept sales representatives.
In accession to sales force amplification in the United States, Amarin affairs to assignment with its all-embracing ally to abutment authoritative efforts alfresco the United States based on REDUCE-IT results. As ahead declared in the months arch up to REDUCE-IT results, Amarin added its Vascepa account levels in alertness for absolute results.
Overall managed affliction allowance advantage for Vascepa has been broad. Amarin looks advanced to alive with allowance carriers to access compassionate of REDUCE-IT after-effects and the abeyant allowances Vascepa could accompany to abounding millions of patients.
REDUCE-IT Abstraction Background
The REDUCE-IT cardiovascular outcomes abstraction commenced in 2011, enrolled and followed 8,179 randomized patients, and was conducted based on a appropriate acceding appraisal acceding with FDA.
REDUCE-IT is the aboriginal all-around cardiovascular outcomes abstraction to prospectively appraise the aftereffect of Vascepa, or any therapy, in developed patients with LDL-C controlled to amid 41-100 mg/dL (median baseline 75 mg/dL) by statin assay and assorted cardiovascular accident factors including assiduous animated TGs amid 150-499 mg/dL (median baseline 216 mg/dL) and either accustomed cardiovascular ache (secondary blockage cohort) or diabetes mellitus and at atomic one added CV accident agency (primary blockage cohort). The architecture of the REDUCE-IT cardiovascular outcomes abstraction was appear in March 2017 in Analytic Cardiology4 and can be begin in the R&D area on the company’s website at www.amarincorp.com.
The REDUCE-IT antecedent activated whether added cardiovascular accident abridgement above LDL-C controlled with statin assay could be accomplished in aerial accident patients with the accepted cardioprotective furnishings of Vascepa 4 grams/day. Independent of REDUCE-IT, Amarin has formed to added abutment the REDUCE-IT antecedent with appear accurate allegation based on assorted degrees of affirmation that appearance EPA may arrest the atherosclerotic action (e.g., applique accumulation and instability) by beneficially affecting cellular functions anticipation to accord to atherosclerosis and cardiovascular contest and by beneficially affecting lipid, lipoprotein and deepening biomarkers.5, 6, 7, 8, 9
Funding from Amarin was provided to Brigham and Women’s Hospital for Dr. Deepak L. Bhatt’s assignment as the REDUCE-IT abstraction armchair and all-embracing arch investigator.
Conference Alarm and Webcast Information
Amarin will host a appointment alarm at 8:00 a.m. ET, September 24, 2018 to altercate this information. The alarm will be attainable through the broker relations area of the company’s website at www.amarincorp.com. The alarm can additionally be heard via blast by dialing 877-407-8033. A epitomize of the alarm will be fabricated accessible for a aeon of two weeks afterward the appointment call. To apprehend a epitomize of the call, punch 877-481-4010 (inside the United States) or 919-882-2331 (outside the United States). A epitomize of the alarm will additionally be accessible through the company’s website anon afterwards the call. For both dial-in numbers amuse use appointment ID 37638.
Amarin Corporation plc. is a rapidly growing, avant-garde biologic aggregation focused on developing assay to advance cardiovascular health. Amarin’s artefact development affairs leverages its all-encompassing acquaintance in lipid science and the abeyant ameliorative allowances of polyunsaturated blubbery acids. Vascepa (icosapent ethyl) is Amarin’s aboriginal FDA-approved biologic and is accessible by decree in the United States, Lebanon and the United Arab Emirates. Amarin’s bartering ally are advancing added authoritative approvals for Vascepa in Canada, China and the Middle East. For added advice about Amarin, appointment www.amarincorp.com.
About Cardiovascular Ache
Worldwide, cardiovascular ache (CVD) charcoal the #1 gesic of men and women. In the United States CVD leads to one in every three deaths – one afterlife about every 38 abnormal – with anniversary assay amount in balance of $500 billion.10, 11
Multiple primary and accessory prevention trials accept apparent a cogent abridgement of 25% to 35% in the accident of cardiovascular events with statin therapy, abrogation cogent assiduous balance accident admitting the accomplishment of ambition LDL-C levels.5
Beyond the cardiovascular accident associated with LDL-C, genetic, epidemiologic, ytic and real-world abstracts advance that patients with animated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at added accident for cardiovascular disease. 12, 13, 14, 15
About VASCEPA® (icosapent ethyl) Capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule decree artefact consisting of the omega-3 acerbic frequently accepted as EPA in ethyl-ester form. Vascepa is not angle oil, but is acquired from angle through a acrimonious and circuitous FDA-regulated accomplishment action brash to finer annihilate algae and abstract and assure the distinct atom alive ingredient. Vascepa, accepted in accurate abstract as AMR101, has been appointed a new actinic article by the FDA. Amarin has been issued assorted patents internationally based on the different ytic contour of Vascepa, including the drug’s adeptness to lower triglyceride levels in accordant accommodating populations after adopting LDL-cholesterol levels.
Indication and Usage Based on Accustomed FDA-Approved Characterization (not including REDUCE-IT results)
Important Assurance Advice for Vascepa Based on Accustomed FDA-Approved Characterization (not including REDUCE-IT results) (Includes Abstracts from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to 2000 mg/dL)
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been accustomed for use by the United States Food and Biologic Administering (FDA) as an accessory to diet to abate triglyceride levels in developed patients with astringent (≥500 mg/dL) hypertriglyceridemia. Nothing in this columnist absolution should be construed as announcement the use of Vascepa in any adumbration that has not been accustomed by the FDA.
Important Cautionary Advice About Topline Results
Existing and -to-be investors are cautioned not to abode disproportionate assurance on topline results. As with any topline cardiovascular outcomes abstraction result, added REDUCE-IT abstracts appraisal and abstracts absolution will crop added advantageous advice to acquaint greater compassionate of the abstraction outcome. Aspects that could change and appulse the final appraisal of the accumulation of the efficacy/safety abstracts from REDUCE-IT may include: the consequence of the assay account on the primary blended endpoint, its components, accessory endpoints and the primary and accessory accident blockage cohorts; application of which apparatus of the blended or accessory endpoints accept the best ytic significance; the bendability of the primary and accessory endpoints; the bendability of allegation above cohorts and subgroups; tolerability and assurance considerations and risk/benefit considerations; application of REDUCE-IT after-effects in the ambience of added ytic studies; and abstraction conduct and abstracts quality, candor and consistency.
This columnist absolution contains advanced statements, including expectations apropos planned publication, accurate presentation, authoritative assay and accompanying timing thereof; expectations that REDUCE-IT after-effects could advance to a new assay archetype in the accommodating citizenry studied; affairs for sales force, all-embracing and allowance advantage expansion. These advanced statements are not promises or guarantees and absorb abundant risks and uncertainties. In addition, Amarin’s adeptness to finer commercialize Vascepa will depend in allotment on its adeptness to abide to finer accounts its business, efforts of third parties, its adeptness to actualize bazaar appeal for Vascepa through education, business and sales activities, to accomplish bazaar accepting of Vascepa, to accept able levels of agreement from third-party payers, to advance and advance a constant antecedent of bartering accumulation at a aggressive price, to accede with acknowledged and authoritative requirements in affiliation with the auction and advance of Vascepa and to advance apparent aegis for Vascepa. Among the factors that could account absolute after-effects to alter materially from those declared or projected herein accommodate the following: uncertainties associated about with assay and development, ytic trials and accompanying authoritative approvals; the accident that sales may not accommodated expectations and accompanying amount may access above expectations; the accident that patents may not be upheld in apparent action and applications may not aftereffect in issued patents acceptable to assure the Vascepa franchise. A added account and description of these risks, uncertainties and added risks associated with an advance in Amarin can be begin in Amarin’s filings with the U.S. Securities and Exchange Commission, including its best contempo annual address on Anatomy 10-Q. Existing and -to-be investors are cautioned not to abode disproportionate assurance on these advanced statements, which allege alone as of the date hereof. Amarin undertakes no obligation to amend or alter the advice independent in this columnist release, whether as a aftereffect of new information, approaching contest or affairs or otherwise.
Availability of Added Advice About Amarin
Investors and others should agenda that Amarin communicates with its investors and the accessible application the aggregation website https://www.amarincorp.com/), the broker relations website (https://investor.amarincorp.com/), including but not bound to broker presentations and broker FAQs, Securities and Exchange Commission filings, columnist releases, accessible appointment calls and webcasts. The advice that Amarin posts on these channels and websites could be accounted to be actual information. As a result, Amarin encourages investors, the media, and others absorbed in Amarin to assay the advice that is acquaint on these channels, including the broker relations website, on a approved basis. This account of channels may be adapted from time to time on Amarin’s broker relations website and may accommodate amusing media channels. The capacity of Amarin’s website or these channels, or any added website that may be accessed from its website or these channels, shall not be accounted congenital by advertence in any filing beneath the Securities Act of 1933.
1 Yokoyama M, Origasa H, Matsuzaki M, et al. Furnishings of eicosapentaenoic acerbic on above coronary contest in hypercholesterolaemic patients (JELIS): a randomised open-label, addled endpoint ysis. Lancet. 2007;369(9567):1090-1098.2 Saito Y, Yokoyama M, Origasa H, et al. Furnishings of EPA on coronary avenue ache in hypercholesterolemic patients with assorted accident factors: sub-ysis of primary blockage cases from the Japan EPA Lipid Action Abstraction (JELIS). Atherosclerosis. 2008;200(1):135-140.3 Matsuzaki M, Yokoyama M, Saito Y, et al. Incremental furnishings of eicosapentaenoic acerbic on cardiovascular contest in statin-treated patients with coronary avenue disease. Circ J. 2009;73(7):1283-1290.4 Bhatt DL, Steg G, Brinton EA, et al. Rationale and architecture of REDUCE‐IT: Abridgement of Cardiovascular Contest with Icosapent Ethyl–Intervention Trial. Analytic Cardiology. 2017;40:138-148.5 Ganda OP, Bhatt DL, Mason RP, et al. Unmet charge for accessory dyslipidemia assay in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.6 Borow KM, Nelson JR, Mason RP. Biologic plausibility, cellular effects, and atomic mechanisms of eicosapentaenoic acerbic (EPA) in atherosclerosis. Atherosclerosis. 2015;242(1):357-366.7 Nelson JR, Wani O, May HT, et al. Abeyant allowances of eicosapentaenoic acerbic on atherosclerotic plaques. Vascul Pharmacol. 2017;91:1–9.8 Mason RP, Dawoud H, Jacob RF, et al. Eicosapentaenoic acerbic improves endothelial action and nitric oxide bioavailability in a address that is added in aggregate with a statin. Biomed Pharmacother. 2018;103:1231-1237.9 Takamura M, Kurokawa K, Ootsuji H, et al. Long-term administering of eicosapentaenoic acerbic improves post-myocardial infarction cardiac adjustment in mice by acclimation macrophage polarization. J Am Heart Assoc. 2017;6(2). pii: e004560.10 American Heart Association. 2018. Ache and Accomplishment Statistics-2018 Update.11 American Heart Association. 2017. Cardiovascular disease: A cher accountability for America projections through 2035.12 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal alleyway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.13 Toth PP, Granowitz C, Hull M, et al. Aerial triglycerides are associated with added cardiovascular events, medical costs, and ability use: A real-world authoritative claims assay of statin-treated patients with aerial balance cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.14 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular ache – New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.15 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Relations:Elisabeth SchwartzInvestor Relations and Corporate CommunicationsAmarin Corporation plcIn U.S.: 1 (908) [email protected]
Lee M. SternTrout Group In U.S.: 1 (646) [email protected]
Media Inquiries:Christy MaginnBurson-MarstellerIn U.S.: 1 (646) [email protected]
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